Job Description

Element Science is building a world class medical device hardware design team. We are looking for a Design Quality Engineer with a passion for creating devices that save lives. This individual will support the product development team in product design and development in accordance with Design Control requirements. This individual will be responsible for providing quality support and oversight to ensure that the products are developed in compliance with company SOPs and other regulatory requirements. The candidate shall have excellent people skills and a can-do attitude to deliver solution.

RESPONSIBILITIES:

• Represent Quality Engineering in providing guidance to product development team through Design Control to ensure compliance to QSR for a life-saving electromechanical device.
• Develop verification and validation plan for new products and sustaining activities including Test Method Validation, Equipment Qualifications etc.
• Develop test methods, document test protocols and reports to support V&V activities.
• Support NCR, CAPA and Complaints process execution through root cause investigations. 
• Support Supplier Quality activities.
• Execute systemic quality improvements based on quality metrics etc.
• Develop of Risk Management Files per ISO 14971.
• Support improvement of Standard Operating Procedures and/or Work Instruction as part of the Quality System procedure.
• Function as an electrical design SME within the Quality team.
• Mentor junior engineers and other quality team members.
• Other tasks as assigned by the management.

QUALIFICATIONS:

• 7+ years of relevant experience in Medical Device environment.
• Working knowledge of current ISO 13485 standard, QSR, ISO 14971 and IEC 60601-1.
• Bachelor’s Degree in Science or Engineering, Master’s degree is a plus.
• Ability to work in a team environment, manage multi-tasking, and disciplined in completing tasks on schedule.
• Excellent written and verbal communication skills.

BENEFITS:

• Element Science offers a very competitive salary and benefits package including, but not limited to:
• Stock Options
• 90% employer-paid medical, dental, and vision insurance
• Company-paid Basic Life Insurance
• 401(k) retirement plan (Traditional and Roth)
• Competitive Paid Time Off
• Paid Holidays
• FSA (Flexible Spending Accounts)
• HSA (Health Savings Account)
• Employee Assistance Program through PEO
• The salary for this exempt-level position will be based on experience and qualifications within an established pay range.
• Salary Range: $130,000 - $140,000.

Element Science is an Equal Opportunity Employer.  All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law.